Omeprazole

Product NDC: 55111-644
11-digit product format: 551110644
Labeler code: 55111
Product ID: 55111-644_8ebe8fd4-472a-4fb0-3a62-4bb87eb0381d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Dr. Reddy's Laboratories Limited
Application: ANDA078490
Marketing category: ANDA
Marketing start: 2014-03-01
Substance: OMEPRAZOLE
Active strength: 20 mg/1
Pharmacologic classes: Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078490-001	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17
A078490-002	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16
A078490-003	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078490-001	AB
A078490-002	AB
A078490-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078490-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078490-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078490-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078490-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078490-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078490-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078490-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078490-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078490-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078490-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078490-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078490-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078490-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078490-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078490-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078490-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Omeprazole
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
KG60484QX9	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198051	Internal RxNorm lookup
199119	Internal RxNorm lookup
200329	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
603d2d06-c5e8-4378-a422-8dca1a410af7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55111-644-01	Omeprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	34
55111-644-05	Omeprazole	500 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	500	34
55111-644-10	Omeprazole	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	34
55111-644-30	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	34
55111-644-77	Omeprazole	1 in 1 CARTON	CAPSULE, DELAYED RELEASE	1	34
55111-644-77	Omeprazole	7 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE	7	34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55111-644-01	EA - Each	55111-644	c69eaefc-00b0-4064-a34b-4bbe305931d3	1	2024-09-09
55111-644-10	EA - Each	55111-644	359ea8ee-52c2-455c-8ec4-2395517a704b	1	2024-09-09
55111-644-30	EA - Each	55111-644	a0a3ae82-5fa9-488e-9390-77827d187468	1	2024-09-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Omeprazole	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
Omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
D&C Red No. 28	INACTIVE INGREDIENT	767IP0Y5NH	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
gelatin	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
meglumine	INACTIVE INGREDIENT	6HG8UB2MUY	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
RAW SUGAR	INACTIVE INGREDIENT	8M707QY5GH	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
talc	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55111-644	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	30	Current NDC, Legacy NDC, 6 package rows	20240616_603d2d06-c5e8-4378-a422-8dca1a410af7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	PD-Rx Pharmaceuticals, Inc.	96104ea6-c08f-40b5-83f5-d840b317f1fd	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	PD-Rx Pharmaceuticals, Inc.	0344268f-d8e6-48d5-b1e1-f750ed1d8a52	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	St. Mary's Medical Park Pharmacy	4c0cf466-f9e8-390e-e063-6294a90a2ed8	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	e07af8c9-559c-5a93-e053-2a95a90a2c63	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Dr. Reddy's Laboratories Limited	603d2d06-c5e8-4378-a422-8dca1a410af7	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490 ndc (product): 55111-644
Omeprazole	OMEPRAZOLE	NorthStar Rx LLC	40a75dc7-49b7-5c9d-6c5f-d4682ec6922e	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	REMEDYREPACK INC.	63b3982a-b541-4b0d-99d4-93a673e57d46	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	288bdd5e-a0ac-4c5c-abe0-93183a28dcdd	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Northwind Health Company, LLC	4720cc17-013e-074e-e063-6294a90ac1f4	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Redpharm Drug	2fd1acb8-12dc-70b7-e063-6394a90a0399	2025-12-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	American Health Packaging	205652e1-7fbc-4b6a-bbd6-2fd346d812df	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals, Inc.	28515ff8-379d-5356-e063-6394a90af3f3	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	3724b8f7-52ff-a5f8-e063-6294a90acf20	2025-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Quallent Pharmaceuticals Health LLC	8090d4c3-3184-7812-53d7-aa30e14b79d1	2025-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	PHOENIX RX LLC	3b19d724-821b-61dc-e063-6294a90aa4d3	2025-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Advanced Rx of Tennessee, LLC	30955530-56d2-174d-e063-6294a90a413c	2025-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	40f66cac-bc23-43f9-9966-87cce458c996	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	2dcd48e4-9ffc-9cc2-e063-6294a90ae17e	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Coupler LLC	2cdc6809-3b1b-046a-e063-6394a90ae02a	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	a806da8c-5f84-454d-966c-da1c48710f80	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KG60484QX9	OMEPRAZOLE	73590-58-6	OMEPRAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	96104ea6-c08f-40b5-83f5-d840b317f1fd	36
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	96104ea6-c08f-40b5-83f5-d840b317f1fd	36
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	96104ea6-c08f-40b5-83f5-d840b317f1fd	36
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	603d2d06-c5e8-4378-a422-8dca1a410af7	34
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	603d2d06-c5e8-4378-a422-8dca1a410af7	34
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	603d2d06-c5e8-4378-a422-8dca1a410af7	34
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	603d2d06-c5e8-4378-a422-8dca1a410af7	34
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	603d2d06-c5e8-4378-a422-8dca1a410af7	34
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	603d2d06-c5e8-4378-a422-8dca1a410af7	34
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	603d2d06-c5e8-4378-a422-8dca1a410af7	34
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	603d2d06-c5e8-4378-a422-8dca1a410af7	34
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	63b3982a-b541-4b0d-99d4-93a673e57d46	7
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	63b3982a-b541-4b0d-99d4-93a673e57d46	7
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	63b3982a-b541-4b0d-99d4-93a673e57d46	7
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	28515ff8-379d-5356-e063-6394a90af3f3	5
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	205652e1-7fbc-4b6a-bbd6-2fd346d812df	5
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	205652e1-7fbc-4b6a-bbd6-2fd346d812df	5
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	28515ff8-379d-5356-e063-6394a90af3f3	5
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	205652e1-7fbc-4b6a-bbd6-2fd346d812df	5
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	205652e1-7fbc-4b6a-bbd6-2fd346d812df	5
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	28515ff8-379d-5356-e063-6394a90af3f3	5
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	205652e1-7fbc-4b6a-bbd6-2fd346d812df	5
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	2fd1acb8-12dc-70b7-e063-6394a90a0399	3
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	59d8be3f-ba13-4897-9ceb-f8ac6ccc1624	3
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	4c0cf466-f9e8-390e-e063-6294a90a2ed8	3
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	2fd1acb8-12dc-70b7-e063-6394a90a0399	3
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	59d8be3f-ba13-4897-9ceb-f8ac6ccc1624	3
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	4c0cf466-f9e8-390e-e063-6294a90a2ed8	3
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	4c0cf466-f9e8-390e-e063-6294a90a2ed8	3
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	2fd1acb8-12dc-70b7-e063-6394a90a0399	3
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	59d8be3f-ba13-4897-9ceb-f8ac6ccc1624	3
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	3724b8f7-52ff-a5f8-e063-6294a90acf20	2
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	3724b8f7-52ff-a5f8-e063-6294a90acf20	2
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	3724b8f7-52ff-a5f8-e063-6294a90acf20	2
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	c8f2e604-74fa-4205-b41f-32401e2dc59e	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	a806da8c-5f84-454d-966c-da1c48710f80	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	2cdc6809-3b1b-046a-e063-6394a90ae02a	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	30955530-56d2-174d-e063-6294a90a413c	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	3b19d724-821b-61dc-e063-6294a90aa4d3	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	487ff32f-943e-458b-b898-bd7b0290cc49	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	30955530-56d2-174d-e063-6294a90a413c	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	3b19d724-821b-61dc-e063-6294a90aa4d3	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	487ff32f-943e-458b-b898-bd7b0290cc49	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	c8f2e604-74fa-4205-b41f-32401e2dc59e	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	2cdc6809-3b1b-046a-e063-6394a90ae02a	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	a806da8c-5f84-454d-966c-da1c48710f80	1
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	c8f2e604-74fa-4205-b41f-32401e2dc59e	1
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	30955530-56d2-174d-e063-6294a90a413c	1
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	a806da8c-5f84-454d-966c-da1c48710f80	1
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	2cdc6809-3b1b-046a-e063-6394a90ae02a	1
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	3b19d724-821b-61dc-e063-6294a90aa4d3	1
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	487ff32f-943e-458b-b898-bd7b0290cc49	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55111-644-01	55111064401	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-644-01)		2014-03-01	0000-00-00	No	No	Current
55111-644-05	55111064405	500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-644-05)		2014-03-01	0000-00-00	No	No	Current
55111-644-10	55111064410	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-644-10)		2014-03-01	0000-00-00	No	No	Current
55111-644-30	55111064430	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-644-30)		2014-03-01	0000-00-00	No	No	Current
55111-644-77	55111064477	1 BLISTER PACK in 1 CARTON (55111-644-77) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK	1 blister pack	2014-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole	PD-Rx Pharmaceuticals, Inc.	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL	37
Omeprazole	St. Mary's Medical Park Pharmacy	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	5
Omeprazole	Dr. Reddy's Laboratories Limited \| Dr. Reddy's Laboratories Limited - FTO III	2026-03-02	HUMAN PRESCRIPTION DRUG LABEL	34
Omeprazole	REMEDYREPACK INC.	2026-02-19	HUMAN PRESCRIPTION DRUG LABEL	7
Omeprazole	Redpharm Drug	2025-12-25	HUMAN PRESCRIPTION DRUG LABEL	3
Omeprazole	American Health Packaging	2025-12-10	HUMAN PRESCRIPTION DRUG LABEL	5
Omeprazole	NuCare Pharmaceuticals, Inc.	2025-09-29	HUMAN PRESCRIPTION DRUG LABEL	5
Omeprazole	Aphena Pharma Solutions - Tennessee, LLC	2025-09-02	HUMAN PRESCRIPTION DRUG LABEL	2
Omeprazole	PHOENIX RX LLC	2025-07-29	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	Advanced Rx of Tennessee, LLC	2025-03-06	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	Coupler LLC	2025-01-29	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	Preferred Pharmaceuticals Inc.	2025-01-20	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	Quality Care Products, LLC	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	3
Omeprazole	A-S Medication Solutions	2024-12-16	HUMAN PRESCRIPTION DRUG LABEL	3
Omeprazole	A-S Medication Solutions	2024-12-16	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	A-S Medication Solutions	2024-12-16	HUMAN PRESCRIPTION DRUG LABEL	1